Hodgkin's Lymphoma
Conditions
Keywords
Hodgkin, Lymphoma, refractory, relapsed
Brief summary
Test of bendamustine in combination with gemcitabine and vinorelbine could contribute to a higher response rate with the reduction of toxic side effects
Detailed description
The aim of this study is to evaluate bendamustine, gemcitabine and vinorelbine (BeGEV) scheme efficacy as induction therapy to high dose chemotherapy with Allogeneic Hematopoietic Stem-Cell Transplantation (AHSCT) for patients with relapsed/refractory Hodglin's Lymphoma (HL). Four BeGEV courses repeated every 3 weeks in the absence of any reasons listed in the paragraph 7.5; whenever an objective response is observed at disease evaluation performed after IV cycle patients undergo to high dose chemotherapy with AHSCT (conditioning regimens based on preference of each Centre).
Interventions
DRUGBendamustine
Schedule: Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles
DRUGGemcitabine
Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
DRUGVinorelbine
Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles
Sponsors
Armando Santoro, MD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* relapsed/refractory disease after receiving one line of standard chemotherapy * history of classical Hodgkin's Lymphoma (HL) * Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2 * at least one site of measurable nodal disease at baseline ≥ 1.5 cm * Absolute Neutrophils Count (ANC) ≥ 1.5 x 109/L; Platelets count ≥ 75 x 109/L
Exclusion criteria
* Diagnosis of Nodular lymphocyte predominant Hodgkin's lymphoma (NLPHL) * prior radiation therapy ≤ 3 weeks prior to start of study treatment * any concurrent anti-cancer therapy * evidence of another malignancy not in remission or history of such a malignancy within the last 2 years. * aspartate aminotransferase (AST/SGOT) and/or alanine aminotransferase (ALT/SGPT) ≥ 2.5 x upper limit of normal (ULN) or ≥ 5.0 x ULN if the transaminase elevation is due to disease involvement * known history of Human immunodeficiency virus (HIV)seropositivity * hepatitis B virus (HBV) or hepatitis B virus (HCV)active hepatitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | 3 months | response rate after BeGEV in terms of Complete Response (CR)evaluated by fludeoxyglucose Positron emission tomography (FDG-PET) and Computed Tomography (CT-scan) after four cycles. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| overall response rate | 3 months | To assess the response rate after BeGEV in terms of overall response rate (ORR) =Complete Response (CR) plus Partial Response (PR)). |
| mobilization potential of the combination | 3 months | To evaluate the mobilization potential of BeGEV. |
| toxicity of the combination | 3 months | To evaluate the toxicity of BeGEV in terms of haematological and extra-haematological side effects according to CTCAE definitions v 3.0. |
| Progression free survival (PFS), Overall Survival (OS). | 2 years | Progression free survival and overall survival |
Countries
Italy
Contacts
Primary ContactArmando Santoro, MD
Backup ContactRita Mazza, MD
Outcome results
None listed